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Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration

ConditionsCholelithiasesCholecystitisPostoperative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSisli Hamidiye Etfal Training and Research Hospital

About this trial

Laparoscopic cholecystectomy is associated with significant postoperative pain originating from trocar sites, pneumoperitoneum, and visceral irritation. Both local anesthetic infiltration and ultrasound-guided rectus sheath block are commonly used regional analgesic techniques to reduce postoperative pain and opioid consumption. This prospective randomized controlled study aims to compare the effects of these two techniques on postoperative pain scores, opioid requirements, and analgesia-related adverse effects following laparoscopic cholecystectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA (American Society of Anesthesiologists) class I-II patients

Patients aged between 18 and 65 years

Patients undergoing laparoscopic cholecystectomy surgery

Disqualifiers

ASA class III-IV patients

Patients undergoing emergency surgery

Relatives of patients who do not provide consent

Presence of chronic pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rectus Sheath Block

    Procedure/Surgery

    After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration.

  • Local Anesthetic Infiltration

    Procedure/Surgery

    At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: GROUP RSBActive comparator 1 intervention
Group B: GROUP LAIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

NRS Score

Postoperative pain assessment will be performed using the Numeric Rating Scale (NRS). The NRS is a scale in which patients rate their pain intensity numerically from 0 (no pain) to 10 (worst imaginable pain).

Time frame
Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.

Secondary outcomes

1

Opioid Consumption

Postoperative opioid consumption will be evaluated using intravenous patient-controlled analgesia (IV PCA) over 24 hours. PCA will be set in bolus-only mode (10 mg tramadol), without continuous infusion. Patients will be educated preoperatively regarding PCA use and instructed to administer boluses in case of pain. At the end of 24 hours, total opioid consumption will be recorded from the device data, and the time to first bolus administration (time to first analgesic requirement) will also be evaluated.

Time frame
24 hour
2

Adverse Effects

Adverse effects such as hypotension, bradycardia, nausea, vomiting, and local anesthetic systemic toxicity (LAST) occurring within the first 24 postoperative hours will be monitored and recorded.

Time frame
24 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sisli Hamidiye Etfal Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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